An Observational Study Of Comparison Of Two Different Doses Of Intrathecal Clonidine As Adjuvant With Hyperbaric levobupivacaine for subarachnoid blockage characteristics In Femur Fracture Surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- to study the sensory and motor blockage characteristics in spinal anaesthesia
研究概览
简要总结
Background
Femur fractures are common injuries that often require surgical intervention, typically managed under spinal anesthesia. Hyperbaric levobupivacaine is widely used for its effective analgesic properties, but the addition of adjuvants can enhance its effects. Clonidine, an alpha-2 adrenergic agonist, has been shown to prolong anesthesia and improve analgesia when used in spinal anesthesia.
Purpose
The purpose of this trial is to compare the effects of two different doses of intrathecal clonidine when used as an adjuvant to hyperbaric levobupivacaine in patients undergoing femur fracture surgeries. The study aims to assess differences in analgesic efficacy, onset and duration of sensory and motor block, and the incidence of side effects, ultimately guiding clinical practice in managing postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to sign informed consent.
- •ASA I & ASA II patients undergoing spinal anaesthesia posted for Femur Fracture Surgeries.
- •Age between 18- 65 years.
- •4.No known history of allergy, sensitivity or other form of reaction to local anesthetics of the ester and amide type.
排除标准
- •Patient refusal.
- •Allergy to any drugs including test drug.
- •History of seizure disorder.
- •Patient taking clonidine or any other antihypertensives.
- •Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
- •ASA III, IV, Patients.
- •Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities).
结局指标
主要结局
to study the sensory and motor blockage characteristics in spinal anaesthesia
时间窗: motor and sensory blockage characteristics assessed at 0,2,4,6,8,10 minutes then every 5 minutes upto 30 minutes and then every 15 minutes till the end of surgery.
次要结局
- To Assess Sedation Score, Duration of Absolute(Analgesia and Effective Analgesia, Number of)
研究者
Radhika Jain
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre